Ensures that product development projects and changes to current products are conducted in compliance with the FDA Quality System Regulation Design Phases and within Exactech Quality Management System.
Participates in cross-functional teams to review requirements to develop product requirements that support the marketing needs.
Participates in cross-functional team to develop risk managements files (plans, assessments and reports)
Review new and modified product design for manufacturability, inspectability and critical to quality characteristics.
Develops Quality inspection plans.
Assists on the purchases of inspection equipment and fixtures as required.
Provide guidance and direction for testing methods and adequate sample size using statistically valid techniques to support verification and validation requirements.
Provides design and process verification and validation expertise during protocol development and execution
Develops and validates, using statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes and components.
Assist, when appropriate, with internal and supplier audits.
Leads and/or participates in company-wide Corrective and Preventive Actions projects.
Provide Quality support to facilitate resolution of product nonconformities.
Assists in product/process analysis and investigations related to customer complaints.
Direct or assist training of QC inspectors and QE technicians on inspection methodologies.
Provides leadership role on championing departmental or cross-functional engineering initiatives.
Act as an effective leader/team member in supporting quality disciplines, decisions and practices.
Provide sound problem-solving methodologies in identifying, prioritizing, communication and resolving quality issues.
May act as independent reviewer for technical documentation.
Know and apply the Quality System and any appropriate Federal and International standards.
Assist and support other team members as necessary.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)